Set Bi-Manual I/A Handpieces 21G AK-0439

GUDID 08058340220727

Set Bi-Manual I/A Handpieces 21G

AKTIVE SRL

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

• Primary Device ID: 08058340220727
• NIH Device Record Key: d069f6e4-5185-4195-838c-b8ef87e75547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Set Bi-Manual I/A Handpieces 21G
• Version Model Number: AK-0439
• Catalog Number: AK-0439
• Company DUNS: 433533053
• Company Name: AKTIVE SRL
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052276026361 [Primary]
GS1	08058340220727 [Unit of Use]

FDA Product Code

• KYG: Device, Irrigation, Ocular Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-19
• Device Publish Date: 2024-01-11

Devices Manufactured by AKTIVE SRL

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• 08058340226217 - Phaco Slit Knife 2.4 mm Bevel Up Angled with protection: 2024-01-25 Phaco Slit Knife 2.4 mm Bevel Up Angled with protection
• 08052276001665 - Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protection: 2024-01-25 Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protection
• 08056477557662 - Phaco Slit Knife 2.65 mm Bevel Up Angled: 2024-01-25 Phaco Slit Knife 2.65 mm Bevel Up Angled
• 08058340226224 - Phaco Slit Knife 2.65 mm Bevel Up Angled with protection: 2024-01-25 Phaco Slit Knife 2.65 mm Bevel Up Angled with protection
• 08052276015167 - Phaco Slit Knife 2.65 mm Dual Bevel Angled with protection: 2024-01-25 Phaco Slit Knife 2.65 mm Dual Bevel Angled with protection
• 08056477557679 - Phaco Slit Knife 2.75 mm Bevel Up Angled: 2024-01-25 Phaco Slit Knife 2.75 mm Bevel Up Angled
• 08058340226248 - Phaco Slit Knife 2.75 mm Bevel Up Angled with protection: 2024-01-25 Phaco Slit Knife 2.75 mm Bevel Up Angled with protection